Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT03132532 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1623NCI-2017-0248116-008343
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized phase II trial studies how well platinum doublet chemotherapy and proton beam radiation therapy work in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as carboplatin, paclitaxel, etoposide, cisplatin, and pemetrexed work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving platinum doublet chemotherapy and proton beam radiation therapy may work better in treating patients with non-small cell lung cancer.

Conditions

Recurrent Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Unresectable Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Progression Free Survival (PFS)

  A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated

  From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years

Secondary Outcomes (4)

• Overall Survival (OS)

  From randomization to death due to any cause, assessed up to 5 years

• Number of Participants With Adverse Events

  Up to 5 years

• Proportion of Participants With Local-regional Failure

  Up to 5 years

• Proportion of Participants With Distant Metastasis

  Up to 5 years

Other Outcomes (1)

• Quality of Life Post Treatment

  Up to 5 years

Study Arms (2)

Arm A (platinum doublet chemotherapy, lower dose PBT)

EXPERIMENTAL

Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Paclitaxel; Drug: Pemetrexed; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm C (platinum doublet chemotherapy, higher dose PBT)

EXPERIMENTAL

Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin; Drug: Paclitaxel; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Carboplatin DRUG

Chemotherapy

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm A (platinum doublet chemotherapy, lower dose PBT); Arm C (platinum doublet chemotherapy, higher dose PBT)

Cisplatin DRUG

Chemotherapy

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm A (platinum doublet chemotherapy, lower dose PBT)

Etoposide DRUG

Chemotherapy

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16

Arm A (platinum doublet chemotherapy, lower dose PBT)

Paclitaxel DRUG

Chemotherapy

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm A (platinum doublet chemotherapy, lower dose PBT); Arm C (platinum doublet chemotherapy, higher dose PBT)

Pemetrexed DRUG

Chemotherapy

Also known as: MTA, Multitargeted Antifolate, Pemfexy

Arm A (platinum doublet chemotherapy, lower dose PBT)

Proton Beam Radiation Therapy RADIATION

Undergo PBT

Also known as: PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, Radiation, Proton Beam

Arm A (platinum doublet chemotherapy, lower dose PBT); Arm C (platinum doublet chemotherapy, higher dose PBT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (platinum doublet chemotherapy, lower dose PBT); Arm C (platinum doublet chemotherapy, higher dose PBT)

Questionnaire Administration OTHER

Ancillary studies

Arm A (platinum doublet chemotherapy, lower dose PBT); Arm C (platinum doublet chemotherapy, higher dose PBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Histological confirmation of non-small cell lung cancer
• Forced expiratory volume in 1 second (FEV1) \> 1.0 L
• Unresectable or medically inoperable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography \[CT/PET\], magnetic resonance imaging \[MRI\] or CT of brain, and physical exam);
• Eligible if recurrence after surgery and now has the equivalent stage 2-3 non-small cell lung cancer (NSCLC) OR had sub totally resected stage 2-3 NSCLC
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
• White blood cell (WBC) \>= 3.0 x 10\^9/L
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Hemoglobin (Hgb) \>= 9 g/dl
• Platelets (plts) \> 100 x 10\^9/L
• Serum creatinine \< 1.5 x upper limits of normal (ULN)
• Serum bilirubin \< 1.5 x ULN
• Provide informed written consent
• Willing to return to enrolling institution for follow-up for a minimum of 1 year

You may not qualify if:

• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Weight loss of \> 10% in the past 3 months
• Distant metastases (M1 disease)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, lupus, usual interstitial pneumonitis (UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
• Active second malignancy
• History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Received chemotherapy for lung cancer within 6 months of registration
• Previous chest radiotherapy that would overlap with the proton field

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Etoposide; Paclitaxel; Taxes; Pemetrexed; Proton Therapy; Protons

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Hydrogen; Gases; Nucleons; Elementary Particles; Physical Phenomena

Results Point of Contact

• Title: Dr. Steven E. Schild
• Organization: Mayo Clinic

sschild@mayo.edu

480-342-4800

Study Officials

• Terence T. Sio, M.D., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: July 31, 2017
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2024-01

Locations

US (2)